NDAINTRAVENOUSPOWDER
Approved
Jan 2025
Lifecycle
Growth
Competitive Pressure
8/100
Clinical Trials
5
Data completeness
5/8 — Partial
GRAFAPEX (treosulfan) by Medexus Pharmaceuticals is 12. First approved in 2025.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GRAFAPEX (treosulfan) is an intravenous alkylating agent approved by FDA on January 21, 2025, for use as a hematopoietic stem cell conditioning agent. The drug works by alkylating DNA to deplete hematopoietic stem cells while providing immunosuppressive effects, making it suitable for patients requiring bone marrow transplantation. Treosulfan is a prodrug that converts to active metabolites (monoepoxide and diepoxibutane) under physiological conditions.
Growth3.3 years to LOE
Recently approved specialty IV product in growth stage with limited current market penetration; small team focused on rapid market establishment in HSCT specialty setting.
Mechanism of Action
12.1 Mechanism of Action Treosulfan is an alkylating agent. DNA alkylation is thought to be responsible for the cytotoxic activities of treosulfan. Treosulfan showed hematopoietic stem cell depleting activity as well as immunosuppressive and antitumor activity in mouse models of leukemia. 12.2…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.